MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR SPRINT RX; STENT, CORONARY, DRUG-ELUTING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Reocclusion (1985); Thrombus (2101); Blood Loss (2597)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

Title: impact of angiographic coronary artery disease complexity on ischemic and bleeding risks and on the comparative effectiveness of zotarolimus-eluting vs.Bare-metal stents in uncertain drug-eluting stent candidates authors: giuseppe gargiulo, athanasios patialiakas, raffaele piccolo, attila thury, salvatore colangelo, gianluca campo, matteo tebaldi, imre ungi, stefano tondi , marco roffi , alberto menozzi, nicoletta de cesare , roberto garbo, emanuele meliga, luca testa, henrique mesquita gabriel, marco ferlini, francesco liistro, antonio dellavalle, pascal vranckx, carlo briguori, stephan windecker, marco valgimigli journal: international journal of cardiology year 2018 issue #:9.120 literature reference: doi.Org/10.1016/j.Ijcard.2018.09.120.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted which documents the post-hoc analysis of the zeus trial.The impact of coronary anatomic complexity measured by the syntax score on the differences in outcomes following zes and bms was assessed at 1 year.Patients were typicallyhigh risk patients with high risk of bleeding or thrombosis or at low restenosis risk.Medtronic endeavor sprint devices were used.Clinical event included cardiac and non cardiac death, stent thrombosis, restenosis, mi, stroke and bleeding incidences were reported in the population under review.

• Brand Name: ENDEAVOR SPRINT RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8173207
• MDR Text Key: 130616706
• Report Number: 9612164-2018-03677
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR